Assoc Director, Regulatory Affairs
Core
Develop and drive Japan labeling strategy across the product lifecycle, serve as the person in charge of CTD M1.8 and Japan Package Insert, and act as the Japan regulatory authority on labeling matters.
Role type
Senior regulatory affairs leader (Japan labeling)
Builds
Japan Package Insert (Labeling), CTD M1.8, and related regulatory documents for Gilead's therapies
Domain
Pharmaceuticals, Japan regulatory environment
Required skills
Strategic labeling leadership, PMDA interaction, CTD M1.8 management, benefit-risk communication, cross-functional collaboration, regulatory compliance, vendor management, scientific writing, risk assessment, project management
Preferred skills
Oncology/Virology/Cell Therapy experience, team leadership, global regulatory experience, accelerated development pathways (SAKIGAKE), Veeva Vault RIM proficiency
Technologies
Veeva RIM, Veeva Vault RIM, PMDA JPI website
Responsibilities
Develop Japan labeling strategy, lead regulatory assessment for labeling updates, represent Japan Regulatory Affairs in global forums, partner with global and local functions, ensure compliance with Japanese regulations, mentor regulatory professionals, manage external vendors
Seniority
Senior, hands-on IC with leadership responsibilities